Aseptic Coupling Devices

ABSTRACT

A seal member for an aseptic coupling device includes a cross-sectional area including a first end portion, a middle portion, and a second end portion opposite the first end portion, the middle portion being thinner in radial dimension than the first and second end portions.

RELATED APPLICATIONS

This application claims the benefit of U.S. Patent Application Ser. No.61/160,603 filed on Mar. 16, 2009, the entirety of which is herebyincorporated by reference.

BACKGROUND

Aseptic coupling devices can be used to connect two or more sterilizedpathways. For example, aseptic coupling devices can be used to couple afluid pathway from a first piece of processing equipment or container toa fluid pathway from a second piece of processing equipment or containerto establish a sterile pathway for fluid transfer therebetween.

Typical aseptic coupling devices require a “dry-to-dry” or “dryconnection” that is created using one or more pathway clamping devicesplaced upstream of the aseptic coupling devices so that the asepticcoupling devices are kept free of fluid while the connection between theaseptic coupling devices is made. Once the sterile connection betweenthe aseptic coupling devices is made, the clamping devices are removedto allow fluid to flow through the aseptic coupling devices.

SUMMARY

In examples described herein, a seal member for an aseptic couplingdevice includes a cross-sectional area including a first end portion, amiddle portion, and a second end portion opposite the first end portion,the middle portion being thinner in radial dimension than the first andsecond end portions.

DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments are described with referenceto the following figures, which are not necessarily drawn to scale,wherein like reference numerals refer to like parts throughout thevarious views unless otherwise specified.

FIG. 1 is a schematic view of an example system including first andsecond pieces of processing equipment and an aseptic coupling deviceforming a sterile connection therebetween.

FIG. 2 is a perspective view of an example aseptic coupling arrangementin a pre-coupled state.

FIG. 3 is a top view of the aseptic coupling arrangement of FIG. 2.

FIG. 4 is a cross-sectional view of the aseptic coupling arrangement ofFIG. 3.

FIG. 5 is an end view of the aseptic coupling arrangement of FIG. 2.

FIG. 6 is another end view of the aseptic coupling arrangement of FIG.2.

FIG. 7 is a cross-sectional view of the aseptic coupling arrangement ofFIG. 2 in a coupled state.

FIG. 8 is a perspective view of the aseptic coupling arrangement of FIG.2 in an uncoupled state.

FIG. 9 is a perspective view of an inner member of the male asepticcoupling of FIG. 2.

FIG. 10 is a side view of the inner member of the male aseptic couplingof FIG. 9.

FIG. 11 is a perspective view of the locking ring of the male asepticcoupling of FIG. 2.

FIG. 12 is a side view of the locking ring of the male aseptic couplingof FIG. 11.

FIG. 13 is an end view of the locking ring of the male aseptic couplingof FIG. 11.

FIG. 14 is a perspective view of a female aseptic coupling of FIG. 2.

FIG. 15 is a side view of the female aseptic coupling of FIG. 14.

FIG. 16 is a bottom view of the female aseptic coupling of FIG. 14.

FIG. 17 is an end view of the female aseptic coupling of FIG. 14.

FIG. 18 is a perspective view of an example clip.

FIG. 19 is an example method for connecting the aseptic coupling device.

FIG. 20 is a first perspective view of another aseptic couplingarrangement in a pre-coupled state.

FIG. 21 is a first exploded perspective view of the male coupling deviceof the arrangement of FIG. 20.

FIG. 22 is a second exploded perspective view of the male couplingdevice of the arrangement of FIG. 20.

FIG. 23 is a perspective view of another aseptic coupling arrangementhaving a coupler attached thereto.

FIG. 24 is a side view of the aseptic coupling arrangement of FIG. 23.

FIG. 25 is a cross-sectional view of the aseptic coupling arrangement ofFIG. 23.

FIG. 26 is a first perspective view of the male and female asepticcoupling devices of FIG. 2 in an uncoupled state and with caps attachedthereto.

FIG. 27 is a second perspective view of the male and female asepticcoupling devices of FIG. 2 in an uncoupled state and with caps attachedthereto.

FIG. 28 is an end view of the cap of the male aseptic coupling device ofFIG. 26.

FIG. 29 is a side view of the cap of the male aseptic coupling device ofFIG. 26.

FIG. 30 is a perspective view of the cap of the female aseptic couplingdevice of FIG. 26.

FIG. 31 shows a side view of the cap of the female aseptic couplingdevice of FIG. 26.

FIG. 32 is an end view of the cap of the female aseptic coupling deviceof FIG. 26.

FIG. 33 is another cross-sectional view of the aseptic couplingarrangement of FIG. 2 in a coupled state.

FIG. 34 is a side view of another example membrane for an asepticcoupling device.

FIG. 35 is a front view of the membrane of FIG. 34.

FIG. 36 is a perspective view of the membrane of FIG. 34.

DETAILED DESCRIPTION

Various embodiments will be described in detail with reference to thedrawings, wherein like reference numerals represent like parts andassemblies throughout the several views. Reference to variousembodiments does not limit the scope of the claims attached hereto.Additionally, any examples set forth in this specification are notintended to be limiting and merely set forth some of the many possibleembodiments for the appended claims.

As used herein, the term “sterilize” means a process of freeing, to aspecified degree, a surface or volume from microorganisms. In exampleembodiments, the sterility of various components can be achieved usingone or more sterilization techniques, including gamma irradiation,E-beam, ethylene oxide (EtO), and/or autoclave technologies.

As used herein, the term “aseptic” refers to any process that maintainsa sterilized surface or volume.

As used herein, the term “fluid” means any substance that can be made toflow including, but is not limited to, liquids, gases, granular orpowdered solids, mixtures or emulsions of two or more fluids,suspensions of solids within liquids or gases, etc.

Referring now to FIG. 1, an example system 100 is shown. System 100includes a first piece of processing equipment 110 and a second piece ofprocessing equipment 120. In example embodiments, equipment 110 and 120are bioreactors including biomaterial. In other embodiments, equipment110 and 120 can be other apparatuses that require a sterile connectiontherebetween such as, for example, a bioreactor and a media bag or otherreceptacle.

Equipment 110 includes a fluid pathway 112 extending therefrom that isterminated by an aseptic coupling arrangement 121 including a firstaseptic coupling device 114. Likewise, equipment 120 includes a fluidpathway 122 extending therefrom that is terminated by a second asepticcoupling device 124 of the aseptic coupling arrangement 121. In exampleembodiments, the environment within pathways 112 and 122 and asepticcoupling devices 114 and 124 are sterile.

Aseptic coupling device 114 can be connected to aseptic coupling device124. Once aseptic coupling device 114 is connected to aseptic couplingdevice 124, a sterile fluid pathway is established between equipment 110and equipment 120. Once the sterile fluid pathway is established, fluidcan be transferred from equipment 110 to equipment 120, or vice versa.

Referring now to FIGS. 2-6, aseptic coupling devices 114 and 124 areshown in a pre-coupled state. In this state, the aseptic couplingdevices 114, 124 are connected to one another. However, a sterile flowpath has not yet been created because membranes associated with theaseptic coupling devices 114, 124 have not yet been removed.

In the example shown, aseptic coupling device 114 is a male couplingdevice, and aseptic coupling device 124 is a female coupling device. Inthe example shown, the devices 114, 124 are keyed so that the devices114, 124 can only be coupled in one manner, as described below. Inalternative embodiments, other configurations are possible.

In the example shown, the male aseptic coupling device 114 includes aninner member 201, a locking ring 202, and a membrane 204. See FIGS.9-13.

Inner member 201 defines a fluid passage 502 through aseptic couplingdevice 114. Inner member 201 is coupled to a portion 214. In the exampleshown, portion 214 is barbed so that portion 214 can be connected to afluid pathway (e.g., 112) such as a hose. Inner member 201 also includesa circular channel 504 that is formed to allow inner member 201 to berotatably coupled to locking ring 202, as described below.

Inner member 201 also defines a channel 304. See FIGS. 8-10. Channel 304is sized to receive a clip 212 (see FIG. 18) that is used to coupleaseptic coupling device 114 to aseptic coupling device 124.

Membrane 204 is coupled, using, for example, an adhesive, to a frontsurface 802 of inner member 201. As shown in FIG. 9, in exampleembodiments, front surface 802 includes an opening 804. Opening 804allows fluid flow through inner member 201. Front surface 802 forms agenerally “D” shape and surrounds the opening 804. An upper portion 809of the front surface 802 allows membrane 204 to extend beyond opening804 so that as membrane 204 is removed, the sterility of opening 804 ismaintained even if membranes 204, 206 are pulled at different rates, asdescribed below. Recess portions 806 and 808 are relief areas thatminimize excessive pull forces.

Inner member 201 also has stops 313 formed adjacent front surface 802.As described further below, stops 313 engage complementary structures onthe mating device to define a coupled position.

In example embodiments, a seal member 532 is positioned in a window 531formed by the inner member 201. Seal member 532 is positioned to engagea corresponding seal member 533 positioned in a window 535 on asepticcoupling device 124 when aseptic coupling devices 114, 124 are connectedand membranes 204, 206 are removed, as described below. See FIG. 7.

As shown in FIGS. 2, 4, 5, 8, 16, and 17, membrane 204 extends throughan opening 313 formed in the device 124. A handle portion 520 is coupledto an end 522 of membrane 204. In example embodiments, the handleportion 520 includes one or more attachment members 208, such asattachment members/apertures, that are positioned to engage attachmentmembers 210 on corresponding membrane 206 of the aseptic coupling device124, as described further below.

Locking ring 202 includes a tab portion 506 that is positioned to bereceived in channel 504 formed by inner member 201. See FIGS. 4, 11, and12. This allows locking ring 202 to be spun in a direction 508 (see FIG.5) to lock aseptic coupling device 114 to aseptic coupling device 124,as described below. Knurls 507 formed on the locking ring 202 allow theuser to easily grasp and rotate the locking ring 202.

Locking ring 202 also includes barbs 203 (see FIGS. 4 and 13) extendingfrom and spaced about an inner periphery of locking ring 202. As shownin FIGS. 8-10 and described further below, barbs 203 are received incorresponding channels 306 formed by aseptic coupling device 124 tocouple aseptic coupling device 114 thereto. In one embodiment, fourbarbs 203 are spaced radially about the inner periphery of locking ring202.

Aseptic coupling device 124 includes a front portion 530 configured tobe coupled to aseptic coupling device 114, and a barbed portion 216configured to be coupled to a fluid source. A fluid passage 503 isformed therethrough.

Front portion 530 includes channels 306 that extend from a front edge307 of front portion 530. In the example show, each channel 306 includesan inlet portion 902 that extends generally axially, and a lockingportion 904 that extends generally radially. The inlet portion 902 issized to receive one barb 203 of locking ring 202 of aseptic couplingdevice 114. When the locking ring 202 is rotated in direction 508, barb203 extends into and is captured by locking portion 904 of channel 306.In example embodiments, three channels 306 are spaced axially aboutfront portion 530 to correspond to barbs 203 of locking ring 202.

Front portion 530 also defines slots 311 that are positioned to receiveclip 212. Barbs 1002 on clip 212 engage a bottom surface 317 of device124 (see FIG. 18). Ramped portions 1004 on each side arm 1006 of theclip 212 extend radially inward through slots 311 to engage channel 304on aseptic coupling device 114. The ramped surfaces of the rampedportions 1004 allow the device to ride along the ramped portions 1004and push arms 1006 away from one another to clear the ramped portions1004. Upon clearance, the ramped portion 1004 move back into placewithin channel 304 to couple the devices 114, 124. In one example, theramped portions 1004 make a “clicking” noise as they clear and enter thechannel 304 to provide the user with audible and/or tactile feedback ofa positive coupling.

Membrane 206 is coupled to a front surface 910 of aseptic couplingdevice 124. See FIG. 17. In examples, surface 910 is generally “D”shaped and surrounds opening 908. Similar to front surface 802, an upperportion 909 of front surface 910 allows membrane 206 to extend beyondopening 908 so that as membrane 206 is removed, the sterility of opening804 is maintained even if membranes 204, 206 are pulled at differentrates, as described below.

Adjacent front surface 910 are formed stops 913. The stops 913 engagestops 313 on the device 114 when the device is positioned in the coupledstate. The stops 313, 813 define the closes position that the devices114, 124 can come together. See FIG. 33. In this manner, the stops 313,813 define the amount of compression in seals 532, 533 when the devices114, 124 are in the coupled state. The stops 313, 913 thereby maintainthe desired compression and minimize the possibility of side loadleakage.

An end 554 of membrane 206 includes a handle portion 552 that includesattachment members 210 that are positioned to engage attachment members208 on the corresponding membrane 206 of the aseptic coupling device124, as described further below.

Referring now to FIG. 19, an example method 1100 for connecting asepticcoupling device 114 to aseptic coupling device 124 is shown.

First, at operation 1102, front portion 530 of aseptic coupling device114 is inserted into aseptic coupling device 124 along centerline 302.During insertion, barbs 203 are received in inlet portions 902 ofchannels 306. In addition, front portion 530 surrounds inner member 201.When front portion 530 is fully inserted, barbs 1002 of clip 212 arereceived in channel 304 on aseptic coupling device 114. In this position(referred to as “pre-coupled”), aseptic coupling device 114 is coupledto aseptic coupling device 124.

Next, at operation 1104, the attachment members 210 on handle portion552 of membrane 206 are connected to attachment members 208 on handleportion 520 of membrane 204. Once connected, handle portions 520, 552are grasped, and a force in a direction 559 is applied. As membranes204, 206 are pulled in direction 559, membranes 204, 206 roll in on oneanother and seals 532, 533 in ends 201 and 540 of each of asepticcoupling devices 114, 124 engage to form a sterile connection.

Once membranes 204, 206 are removed, locking ring 202 is rotated (stage1106) in direction 508 so that barbs 203 enter locking portions 904 ofchannels 306. As barbs 203 move along locking portions 904, asepticcoupling device 114 is pulled slightly closer to aseptic coupling device124 to compress the seal members 532, 533 together. At this position(referred to as “coupled”), an aseptic pathway exists through passages502, 503 of the aseptic coupling devices 114, 124. See FIG. 7. As notedabove, the stops 313, 913 define the level of compression for the sealmembers 532, 533. See FIG. 33.

Referring now to FIGS. 20-22, an alternative embodiment of an asepticcoupling arrangement 1000 is shown. In the example shown, asepticcoupling device 114 is identical to that described above, and an asepticcoupling device 1124 is a male coupling that is similar to asepticcoupling device 124 describe above.

However, aseptic coupling device 1124 includes a separate inner member1102 and outer member 1104. Inner member 1102 is identical in shape toinner member 201 of aseptic coupling device 114. This allows bothcomponents to be molded using the same machinery.

Outer member 1104 includes a tab portion 1106 with a plurality ofmembers 1107 that are positioned to be received in a channel 1108 formedby inner member 1102. This allows outer member 1104 to be coupled toinner member 1102 and spin relative thereto. Other configurations arepossible.

Referring now to FIGS. 23-25, another example embodiment of an asepticcoupling arrangement 2124 is shown.

In this example, an aseptic coupling device 2152 includes a termination2154 that is sized to be coupled to another coupling device, such as aquick disconnect coupler 1902. Examples of such couplers are describedin U.S. Pat. Nos. D357,307; D384,731; 5,316,041; and 5,494,074. Theentireties of these patents are hereby incorporated by reference. Othertypes of couplers can be used.

As shown, an insert member 2156 is connected (e.g., by sonic welding) tothe termination 2154. The coupler 1902 is, in turn, connected to theinsert member 2156.

In the example shown, the coupler 1902 includes a valving structure1906, and the insert member 2156 includes a valving structure 2158.These valving structures 1906, 2158 are normally open when the coupler1902 is connected to the insert member 2156, so that fluid can flowtherethrough. In such an example, the entire device 2152 can besterilized prior to use.

When fluid flow is complete, a latch 1908 of the coupler 1902 can beactuated to disconnect the coupler 1902 from the insert member 2156positioned between the termination 2154 and the coupler 1902. Whendisconnected, valving structure 1906 in coupler 1920 stops the flow offluid through the coupler 1920, and valving structure 2158 in the insertmember 2156 stops the flow of fluid through the device 2124. This canresult in a disconnect that is also aseptic. The coupler 1902 canthereupon, in turn, be connected to other terminations as desired.

In other embodiments, coupler 1902 can be connected to aseptic couplingdevice 114. In still further embodiments, both aseptic coupling devices114 and 124 can each have a coupler connected thereto. In otherexamples, the coupler 1920 can be welded to the devices 114, 124, andthe insert member 2156 can be coupled to the coupler 1920. Otherconfigurations are possible.

Referring now to FIGS. 26-32, in example embodiments, a cap 3100 can beconnected to aseptic coupling device 124, and a cap 3200 can beconnected to aseptic coupling device 114. The caps 3100, 3200 functionto protect the membranes 204, 206 prior to use. When ready for use, caps3100, 3200 are removed from devices 114, 124 before devices 114, 124 arecoupled.

As shown in FIGS. 28 and 29, the cap 3200 includes a body 3202 that isconcave to surround the front surface 802 of inner member 201of thedevice 114. Tabs 3204 on the body 3202 are received in the channel 304on the inner member 201 to releasably couple the cap 3200 to the device114. A bottom member 3206 guides and protects a lower portion of themembrane 204. The handle portion 520 attached to the member 204 extendsout of the bottom member 3206.

As shown in FIGS. 30-32, the cap 3100 includes a body 3102 that extendsinto the device 124. Slots 3113 on each side of the body 3102 arepositioned to engage ramped portions 1004 of the clip 212 (see FIG. 18)as the cap 3100 is inserted into the front portion 530 of the device 124to releasably hold the cap 3100 to the device 124. Tabs 3105 formed onthe body 3102 allow the user to grasp and remove the cap 3100 prior touse. A bottom member 3106 guides and protects a lower portion of themembrane 206. The handle portion 522 attached to the member 206 extendsout of the bottom member 3106.

Referring now to FIGS. 34-36, another example membrane 950 is shown. Themembrane 950 is similar in construction to membranes 204, 206, and canbe used in conjunction with either or both of the aseptic couplingdevices 114, 124. In the example shown, the membrane 950 includes anenlarged portion 960 positioned at the end of the membrane 950 that isattached to the front surfaces 802, 910 of the devices 114, 124.Specifically, the enlarged portion 960 is spherical in shape so that theportion 960 generally encompasses a larger part of the front surface802, 910 to provide a better sealing between the membrane 950 and thefront surfaces 802, 910. Other configurations are possible.

In example embodiments, the aseptic coupling devices are made of apolymeric material. For example, in one embodiment, the aseptic couplingdevices are made of polycarbonate and the seal members used therein aremade of a silicone rubber. Other materials can be used.

In some embodiments, membranes 204, 206 are autoclavable and gammastable for sterilization. In various embodiments, membranes 204, 206 area composite design that consists of two components: 1 tag and 1 vent.The tag is a laminate including: a polyethylene terephthalate (PET)film, polyethylene (PE) foam, aluminum foil, and a sealing layer. Thefoam and/or foil may or may not exist in the final configuration. Thesealing layer allows the tag to be bonded or welded to polycarbonateconnectors (e.g., aseptic coupling devices 114 and 124). The vent is anexpanded poly(tetrafluoroethylene) (ePTFE) membrane that will be bondedor welded onto the tag. Membranes 204, 206 are located over the centerof the flow area of aseptic coupling devices 114 and 124, respectively,when the tags and vents are bonded or welded to connectors. The ventallows air and steam to flow into the system 100 during sterilization.The pore size of membranes 204, 206 are such that membranes 204, 206filter out microorganisms larger than 0.2 microns.

In another embodiment, membranes 204, 206 are a polyethersulfone (PES)and polyester laminate membrane. This membrane is hydrophobic andbreathable. The pore size is such that microorganisms larger than 0.2microns are filtered out. When bonded, the polycarbonate melts into thepolyester fibers, so that the PES acts as the filter, and the polyesteracts as the structure.

In other embodiments, membranes 204, 206 are a Tyvek membrane that iscoated on one side to allow membranes 204, 206 to be bonded topolycarbonate connectors (e.g., aseptic coupling devices 114 and 124).Tyvek is breathable in nature, so there is no need for an additionalvent. Tyvek is a non-woven polyethylene membrane.

The various embodiments described above are provided by way ofillustration only and should not be construed to limit the claimsattached hereto. Those skilled in the art will readily recognize variousmodifications and changes that may be made without following the exampleembodiments and applications illustrated and described herein, andwithout departing from the true spirit and scope of the disclosure.

What is claimed is:
 1. A seal member for an aseptic coupling device, theseal member comprising a cross-sectional area including a first endportion, a middle portion, and a second end portion opposite the firstend portion, the middle portion being thinner in radial dimension thanthe first and second end portions.
 2. The seal member of claim 1,wherein the middle portion defines semi-circular upper and lower bounds.3. The seal member of claim 2, wherein a first radius of thesemi-circular upper bound differs from a second radius of thesemi-circular lower bound.
 4. The seal member of claim 3, wherein theseal member is configured to be compressed against another seal memberto form a coupled state in which a sterile flow path is created betweenthe aseptic coupling device and another aseptic coupling device.
 5. Theseal member of claim 1, wherein the seal member is configured to becompressed against another seal member to form a coupled state in whicha sterile flow path is created between the aseptic coupling device andanother aseptic coupling device.
 6. An aseptic coupling device,comprising: an inner member defining a fluid passage therethrough; aseal member coupled to a front surface of the inner member, the sealmember having a cross-sectional area including a first end portion, amiddle portion, and a second end portion opposite the first end portion,the middle portion being thinner in radial dimension than the first andsecond end portions; and a membrane coupled to the front surface of theinner member to cover the seal member.
 7. The aseptic coupling device ofclaim 6, further comprising a locking ring positioned to rotate aboutthe inner member.
 8. The aseptic coupling device of claim 7, wherein theinner member is sized to be received in a member of another asepticcoupling device to form a pre-coupled state, wherein, when the membraneis removed, the seal member engages a second seal member of the otheraseptic device, and wherein, upon turning of the locking ring, the sealmember and the second seal member are compressed to form a coupled statein which a sterile flow path is created between the aseptic couplingdevice and another aseptic coupling device.
 9. The aseptic couplingdevice of claim 6, wherein the middle portion defines semi-circularupper and lower bounds.
 10. The aseptic coupling device of claim 9,wherein a first radius of the semi-circular upper bound differs from asecond radius of the semi-circular lower bound.
 11. The aseptic couplingdevice of claim 10, wherein the seal member is configured to becompressed against another seal member to form a coupled state in whicha sterile flow path is created between the aseptic coupling device andanother aseptic coupling device.
 12. The aseptic coupling device ofclaim 6, wherein the seal member is configured to be compressed againstanother seal member to form a coupled state in which a sterile flow pathis created between the aseptic coupling device and another asepticcoupling device.
 13. A method for forming a sterile connection, themethod comprising: forming a seal member, the seal member having across-sectional area including a first end portion, a middle portion,and a second end portion opposite the first end portion, the middleportion being thinner in radial dimension than the first and second endportions; and positioning the seal member in a first aseptic couplingdevice.
 14. The method of claim 13, wherein the middle portion definessemi-circular upper and lower bounds.
 15. The method of claim 14,wherein a first radius of the semi-circular upper bound differs from asecond radius of the semi-circular lower bound.
 16. The method of claim15, wherein the seal member is configured to be compressed againstanother seal member to form a coupled state in which a sterile flow pathis created between the first aseptic coupling device and a secondaseptic coupling device.
 17. The method of claim 13, wherein the sealmember is configured to be compressed against another seal member toform a coupled state in which a sterile flow path is created between thefirst aseptic coupling device and a second aseptic device.
 18. Themethod of claim 13, further comprising inserting the first asepticcoupling device into a second aseptic coupling device.
 19. The method ofclaim 18, further comprising removing a first membrane from the firstaseptic coupling device and a second membrane from the second asepticcoupling device.
 20. The method of claim 19, further comprising rotatinga locking clip on the first aseptic coupling device to compress a firstseal member of the first aseptic coupling device with a second sealmember of the second aseptic coupling device to form a sterile fluidpassageway.